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Pilot Study of DRibble Vaccine for Prostate Cancer Patients

NCT02234921 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2018-10-11

No results posted yet for this study

Summary

This is a pilot study of the DRibble vaccine in patients with advanced prostate cancer.

Conditions

  • Adenocarcinoma of the Prostate

Interventions

DRUG

Cyclophosphamide

A single dose of cyclophosphamide, 300 mg/m2, will be administered intravenously 3 Days prior to the first vaccine.

BIOLOGICAL

DRibble Vaccine

DRibble vaccine will be administered at Weeks 1, 4, 7, 10, 13, 16, 19 and 22. Eight vaccinations will be administered. Week 1 and 4 vaccines will be administered by intranodal injections performed using ultrasound guidance.

BIOLOGICAL

HPV Vaccinations

Patients will receive a dose of 0.5-mL CERVARIX at week 1 (Day 4) and week 7 by intramuscular injection at a site distant from the DRibble vaccine.

DRUG

Imiquimod

Imiquimod cream (5%, 250 mg) will be self-applied topically for 5 consecutive days by patients to a 4 x 5-cm outlined area of healthy extremity skin starting on the day of the second vaccine and again during each additional vaccine cycle.

Sponsors & Collaborators

  • Providence Health & Services

    collaborator OTHER

  • Providence Cancer Center

    collaborator UNKNOWN

  • Providence Cancer Center, Earle A. Chiles Research Institute

    collaborator OTHER

  • UbiVac

    lead INDUSTRY

Principal Investigators

  • Brendan Curti, MD · Providence Health & Services

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-24
Primary Completion
2018-08-15
Completion
2018-08-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02234921 on ClinicalTrials.gov